FDA 510(k) Application Details - K121902

Device Classification Name	Perineometer   More FDA Info for this Device
510(K) Number	K121902
Device Name	Perineometer
Applicant	ORELLE CORPORATION LTD 4739 - 44TH AVE S.W., UNIT 403 SEATTLE, WA 98116 US Other 510(k) Applications for this Company
Contact	PATRICIA COOMBES Other 510(k) Applications for this Contact
Regulation Number	884.1425   More FDA Info for this Regulation Number
Classification Product Code	HIR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2012
Decision Date	06/06/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review